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Recall Observatory FDA recall evidence

Device product

Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Z-2547-2016

July 06, 2016

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 74663
Status
Terminated
Classification
Class II
Quantity
1250 units
Official record key
device-enforcement:Z-2547-2016

Official wording

Reason: May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.

Code information: Lot Number: REZK0479

Distribution pattern: Nationwide Distribution to the following; CA, LA, VA, IA, AR, SC, PA, MA, IL, MO. Foreign distribution to the following; Canada, Belgium, Australia, Taiwan, China, Argentina.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.